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# Acel Rx Resubmits NDA for Pain Drug
- URL: https://www.fdaweb.com/acel-rx-resubmits-nda-for-pain-drug/
- Published: 2018-05-25T12:00:00.000Z
- Updated: 2026-09-15T00:07:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141540

FDA has accepted for review an AcelRx Pharmaceuticals NDA resubmission for Dsuvia (sufentanil sublingual tablet, 30 micrograms) for treating moderate-to-severe acute pain for adult patients in medically supervised settings. FDA has assigned a user fee review action target date of 11/3\. In 10/2017, the agency issued a complete response letter on the original submission, asking for additional safety-related data from at least 50 patients dosed at the maximum amount described in the proposed labeling. Additionally, FDA said that to ensure proper administration of the tablet with the single-dose applicator, it recommended certain changes to the “Directions for Use” to address use-related errors, including dropped tablets, to be validated through a human factors study.